| アブストラクト | INTRODUCTION: Severe cutaneous adverse reactions (SCARs) are rare but potentially life-threatening. Children and adolescents are especially vulnerable due to developmental pharmacology, immature immune systems, and limited premarketing safety data. However, large-scale evidence of drug-specific SCAR patterns in pediatric populations remains limited. AIM: To investigate the epidemiology, clinical features, drug associations, and safety signals of SCARs in children and adolescents using the FDA Adverse Event Reporting System (FAERS). METHOD: Reports of SCARs in patients aged </= 18 years were retrieved from FAERS from Q1 2004 to Q2 2024 and identified using narrow-scope Standardised MedDRA Queries (SMQs). Data cleaning followed the FDA-recommended procedures. Disproportionality analysis was performed using four methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN; yielding Information Component, IC), Multi-item Gamma Poisson Shrinker (MGPS), and empirical Bayes geometric mean (EBGM). Drug-label reviews were used to compare the signal detection results with existing safety warnings. RESULTS: A total of 7183 pediatric SCAR reports were included. The number of reports has increased over time, with adolescents (13-17 years) and school-aged children (7-12 years) accounting for 68% of cases. The most frequently reported Preferred Terms were drug reaction with eosinophilia and systemic symptoms (DRESS; 32.5%), Stevens-Johnson syndrome (SJS; 27.9%), and toxic epidermal necrolysis (TEN; 19.0%). Hospitalization occurred in 64.5% of cases, and 6.3% were fatal. Among the 2005 cases with available onset time, 82.7% developed within 30 days of drug exposure. Thirty-eight drugs showed positive signals, including lamotrigine, phenytoin, sulfamethoxazole, and phenobarbital. Four drugs, ranitidine, anakinra, clonazepam, and rifampin, showed signals without corresponding warnings in the FDA pediatric labeling. CONCLUSION: SCARs in children and adolescents show distinct patterns, high hospitalization and mortality, and strong links with antiepileptics and anti-infectives. Strengthening pediatric pharmacovigilance, implementing risk-alert systems, and promoting genotype-guided prescribing may help prevent these severe reactions. |
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| 組織名 | Department of Pharmacy, Chongqing University Three Gorges Hospital, 165 Xincheng;Road, Wanzhou District, Chongqing, 404000, China.;School of Medicine, Chongqing University, Chongqing, China.;Road, Wanzhou District, Chongqing, 404000, China. 18696850703@163.com.;School of Medicine, Chongqing University, Chongqing, China. 18696850703@163.com. |
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